Ignite Creation Date:
2025-12-25 @ 1:59 AM
Ignite Modification Date:
2025-12-26 @ 1:02 AM
Study NCT ID:
NCT01056094
Status:
UNKNOWN
Last Update Posted:
2012-06-25
First Post:
2010-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Lutein Supplementation on Oxidative Stress and Inflammation in Healthy Nonsmokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014975', 'term': 'Lutein'}], 'ancestors': [{'id': 'D024341', 'term': 'Xanthophylls'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-06-21', 'studyFirstSubmitDate': '2010-01-25', 'studyFirstSubmitQcDate': '2010-01-25', 'lastUpdatePostDateStruct': {'date': '2012-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biomarkers of lipid, protein and DNA oxidative damage, marker of antioxidant capacity and antioxidant enzyme activities(GPx,SOD and CAT)in healthy subjects.', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Oxidative Stress in Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'Lutein is one of oxygenated carotenoids. Over the past few years, there has been increased interest in evaluating the effect of lutein for optimizing immune functions. A large number of epidemiological studies support the notion that a high intake of lutein is associated with a reduced risk of coronary heart disease and certain types of cancer. The biological mechanisms for the protective effects of this carotenoid, including powerful modulation of functions and antioxidant properties, are only partially known. Although several nutrients and phytochemicals have been shown to modulate immune functions in humans, few studies have investigated the role of lutein consumption. No information is available as to whether lutein supplementation could be protective against oxidative stress. Therefore, the objective of the present study was to examine the effect of consuming different doses of lutein on oxidative stress in healthy subjects.', 'detailedDescription': 'Participants with a history of smoking, alcohol consumption, body mass index (BMI)≥30kg/m2, allergies, ocular diseases and participants taking vitamins or other food supplements containing lutein were excluded from the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult subjects aged in the range of 20 to 80\n\nExclusion Criteria:\n\n* Participants with a history of smoking\n* Alcohol consumption\n* Body mass index (BMI)≥30kg/m2\n* Allergies\n* Ocular diseases or recent infections(within the last year) and participants taking vitamins or other food supplements containing lutein the previous 2 months.'}, 'identificationModule': {'nctId': 'NCT01056094', 'briefTitle': 'Effects of Lutein Supplementation on Oxidative Stress and Inflammation in Healthy Nonsmokers', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'Effects of Lutein Supplementation on Oxidative Stress and Inflammation in Healthy Nonsmokers', 'orgStudyIdInfo': {'id': 'CNS-06094'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '20mg Lutein', 'description': 'Dietary Supplement: 20mg Lutein; daily supplementation 12 week', 'interventionNames': ['Drug: Lutein']}, {'type': 'ACTIVE_COMPARATOR', 'label': '10mg Lutein', 'description': 'Dietary Supplement: 10mg Lutein; daily supplementation 12 week', 'interventionNames': ['Drug: Lutein']}, {'type': 'PLACEBO_COMPARATOR', 'label': '0mg Lutein', 'description': 'Dietary Supplement: 0mg Lutein; daily supplementation 12 week', 'interventionNames': ['Drug: Lutein']}], 'interventions': [{'name': 'Lutein', 'type': 'DRUG', 'description': 'Dietary Supplement: 20mg,10mg, 0mg Lutein; daily supplementation 12 week', 'armGroupLabels': ['0mg Lutein', '10mg Lutein', '20mg Lutein']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Le MA, MD', 'role': 'CONTACT', 'email': 'male@mail.xjtu.edu.cn'}], 'facility': "Xi'an Jiaotong University College of Medicine", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'le ma, MD', 'role': 'CONTACT', 'email': 'male@mail.xjtu.edu.cn'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'collaborators': [{'name': "Xi'an Jiaotong University", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Xi'an Jiaotong University College of Medicine", 'investigatorFullName': 'Le MA', 'investigatorAffiliation': "Xi'an Jiaotong University"}}}}